Greatbatch, Inc. Issues Voluntary Field Corrective Action for Standard Offset Cup Impactor

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Greatbatch, Inc. Issues Voluntary Field Corrective Action for Standard Offset Cup Impactor

03/11/2014 06:09 PM EDT

Greatbach, Inc. initiated a voluntary field corrective action for all Standard Offset Cup Impactors after an internal review determined that the sterilization recommendation in the Instructions for Use for the product did not meet requirements for sterility assurance, which has the potential to result in surgical infection. No incidents have been reported during clinical use of the product, nor have there been any reported adverse events.

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